Cholestatic pruritus is chronic itching associated with impaired bile flow in cholestatic liver disease. It can be severe and disabling, with major impacts on sleep, quality of life, and mental health.
The FDA announced major policy changes including requiring only one study for drug approvals instead of two, and offering performance bonuses to reviewers who complete work ahead of schedule while maintaining thoroughness.
GSK agreed to license linerixibat to Alfasigma in a deal worth up to $690 million, while Eisai received orphan drug designation in Japan for E2086, a novel selective orexin 2 receptor agonist for narcolepsy.
The FDA is set to make approval decisions on five drug applications in March 2026, including treatments for psoriatic arthritis, dry eye disease, hypothalamic obesity, cholestatic pruritus, and a rare genetic disorder.
| NCT ID | Title | Status | Phase |
|---|---|---|---|
| NCT03995212 |
Study to Evaluate the Safety and Efficacy of Oral CR845 (Difelikefalin) in Patients With Primary Biliary Cholangitis (PBC) and Moderate-to-Severe Pruritus |
TERMINATED | PHASE2 |
